After ConsumerLab.com, White Plains, NY, released a recent report stating most valerian herbal supplements failed its quality tests, the American Herbal Products Association (AHPA), Silver Spring, MD, issued a challenge to the assessment. After ConsumerLab.com (CL) responded, defending its procedures and conclusion, AHPA reissued its assessment, drawing further criticism from CL.

Among nine products selected for review, only two passed testing, according to CL. Of the seven that failed, one contained no detectable key valerian compounds and four others had only 26.7% to 82.5% of amounts expected from ingredient listings. One of these products was found to be contaminated with lead, as were two other products.

The amounts of lead found in the products (which ranged up to 3.5 mcg of lead per daily serving) are not likely to cause toxicity alone, CL said, but it is best to avoid unnecessary lead exposure. Lead contamination was found to be an issue in products consisting primarily of valerian root powder as opposed to valerian root extract. The extraction process removes heavy metals.

AHPA’s review called into question some of CL’s procedures and suggested that most of the tested products meet standards established by the European Pharmacopoeia (EP) and FDA. According to AHPA, tested products include some that specify the level of valerenic acids and others that list only the amount of valerian root. In the latter case, CL states that a product passed if the amount of total valerenic acids detected was at least 0.17% of the amount of valerian root in the product. This is the minimum amount established by the EP for whole, dried valerian root. But the EP level for valerenic acid from dried valerian root in cut form is 0.10%, reflecting changes that may occur during processing.

Additionally, Steven Dentali, PhD, chief science officer of AHPA, said “While valerenic acids are useful markers for identifying a valerian ingredient, you can’t ‘test in the quality’ of a valerian product simply by measuring these compounds. This narrow approach has in at least one case caused CL to classify a product with proven efficacy as ‘not approved.’”

Tod Cooperman, MD, president of ConsumerLab.com, issued several responses to AHPA’s evaluation of the review. “In an apparent attempt to defend the reputation of products that have failed to meet our quality criteria, the AHPA trade group has overlooked key facts that clearly support ConsumerLab.com’s findings and conclusions,” he said. “AHPA is misleading the public with false information. We encourage AHPA to instead use its resources to improve the quality of valerian supplements in the marketplace, as there are products containing little of their listed ingredients.”

As for lead levels, CL utilized the California limit (0.5 mcg/day is the level above which products sold in the state of California are required to bear warning labels).

But this California standard is inconsistent with other established limits on lead, according to AHPA. For example, Health Canada allows up to 20 mcg/day of lead in natural health products (the Canadian equivalent of dietary supplements in the U.S.). And while FDA has not issued a regulation to provide quantitative limits for lead or other heavy metals in supplement products (or in most conventional foods), FDA’s Principal Deputy Commissioner Joshua Sharfstein, MD, referenced 6 mcg/day as “FDA’s tolerable daily intake” for lead in testimony before Congress earlier this year, referring to the agency’s long-established provisional total tolerable intake (PTTI) of lead in the most sensitive population of children under 7.

In his latest remarks about the dispute, Dr. Cooperman said: “The question in our minds at ConsumerLab.com when we choose criteria for evaluating supplements is not ‘what are the minimum standards required by a manufacturer?’ but ‘what criteria best meet the needs of consumers, including our own families, who rely on our information?’ It should not be surprising that the criteria selected by ConsumerLab.com often exceed the minimums chosen by the industry. This explains why, for example, we hold herbal products to the strict California State limit of 0.5 mcg of lead per daily serving, as opposed to AHPA’s preferred limit of 10 mcg of lead per daily serving. Eleven years of product testing show that our standards are not only achievable, but that many of the products on the market can meet our criteria.”